United Therapeutics (UTHR) investor relations material

Recent clinical trial highlights

• Two successful clinical trials reported: nebulized Tyvaso in idiopathic pulmonary fibrosis (IPF) and ralinepag in pulmonary arterial hypertension (PAH), both showing strong efficacy with p-values <0.0003.

• Both therapies are on track for FDA filings by the end of summer, with ralinepag as an NDA and Tyvaso for an sNDA.

• Tyvaso DPI continues to show strong growth prospects in PH-ILD, supported by a robust partnership and positive patient outcomes.

• Expansion of the sales force is underway to support anticipated launches and growth in new indications.

• The company is preparing for significant commercial opportunities in IPF and PPF, with ongoing pivotal programs.

Financial outlook and growth strategy

• Management maintains confidence in achieving a $1 billion quarterly run rate by the end of 2027, driven by commercial products and pipeline launches.

• Growth is expected primarily from the Tyvaso franchise, especially Tyvaso DPI in PH-ILD.

• Revenue is projected to potentially double beyond 2027, with major contributions from nebulized Tyvaso in IPF.

• No anticipated price change for Tyvaso with the addition of the IPF indication.

• Ongoing investments in sales and operational readiness to support new product launches and market expansion.

Pipeline and product development

• Pivotal PPF trial for Tyvaso is 75% enrolled, with high confidence in achieving results similar to IPF due to overlapping disease mechanisms.

• Tyvaso Soft Mist Inhaler (SMI) filing is planned for later this year, targeting PAH and PH-ILD, with ongoing healthy volunteer studies.

• Ralinepag demonstrated strong efficacy in PAH and is positioned for earlier use in the treatment paradigm, with plans for DPI formulation development.

• Expansion into PH-COPD is underway using the SMI, leveraging learnings from previous trials and improved patient selection.